|Publication number||US4079468 A|
|Application number||US 05/735,576|
|Publication date||Mar 21, 1978|
|Filing date||Oct 26, 1976|
|Priority date||Jan 1, 1976|
|Publication number||05735576, 735576, US 4079468 A, US 4079468A, US-A-4079468, US4079468 A, US4079468A|
|Inventors||Domingo Santo Liotta, Helio Mario Ferrari, Amadeo Joaquin Pisanu, Fidel Osvaldo Donato|
|Original Assignee||Domingo Santo Liotta, Helio Mario Ferrari, Amadeo Joaquin Pisanu, Fidel Osvaldo Donato|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (1), Non-Patent Citations (1), Referenced by (104), Classifications (8), Legal Events (1)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This invention relates to prosthetic devices, and in particular to low profile gluteraldehyde-fixed porcine aortic xenografts. More particularly, the invention tion is concerned with a low profile gluteraldehyde-fixed cardiac valve prepared from a porcine aortic valve.
Gluteraldehyde solution employed for fixation and preservation of the porcine and aortic valve is the same as the method of other tissue valves, for example, the Hancock type, the Carpentier type, etc. In addition, another feature in common with other tissue valves is the use of a frame in which the porcine aortic valve is mounted.
Anatomical studies demonstrate that in 90% of the specimens the depth of the sinuses of Valsalva were under 10 mm. Also, the aortic ridge is an important structure that joins the three commissures. The anatomic conclusions indicated the need and necessity of providing a low profile bio-prosthesis preserving the aortic ridge.
Protrusion of the frame into the LV (Left Ventricle) with risk of obstruction by the trabecular muscles, perforation of the posterior wall of LV and mainly various degrees of subaortic obstruction have been reported with the use of the current mounted aortic porcine xenograft. In addition, small ascending aorta will not freely accept a bulky prosthesis.
The complications with the low profile prosthetic heterograft are completely avoided.
Furthermore, the tissue valve will perform better and last longer because the normal functional architecture of the cusps are maintained.
The improved cardiac valve development was originated from a fundamental anatomic study, focusing on the size and dimension of 200 porcine aortic valves. The majority of the specimens examined revealed that the distance between the aortic ridge is under 11 mm, measured at the lower point in the sinus of Valsalva. These studies demonstrated the need for a low profile cardiac valve, preserving the anatomic relations of the porcine aortic valve. The observations were made before dissection and separation of the aortic valve from the surrounding anatomic structures in the heart.
The cardiac valve according to the invention has three distinct advantages over the other tissue valves.
1. It eliminates the intraventricular or the intra-aortic struts.
2. When implanted in the atrioventricular position, most of the body of the bio-prosthesis (10 mm height in the largest valve) remains in the atrium's cavity.
3. The aortic ridge and partially the sinuses of Valsalva are preserved.
A major source of complications and death shortly after valve replacement with a tissue valve is due to the inadequate space in the cardiac ventricle or in the ascending aorta to accommodate the valve readily, and to too small a ventricular cavity or aortic root to freely accept the bio-prosthesis. Consequently, the removal of the intraventricular and most of the intra-aortic portion of the bio-prosthesis prevents valve dysfunction produced by tissue valve disproportion.
In addition, obstruction of the outflow tract of the ventricle and impingement of the valve's frame on the intraventricular septum or on the left ventricular wall are definitively suppressed. Prosthetic dysfunction by prosthetic disproportion may also be served after valve replacement with a mechanical prosthesis, such as caged-ball and caged-disc prosthesis.
After implantation in the mitral annulus, most of the body of the new bio-prosthesis remains in the atrium's cavity. For example, 10 mm out of the 14 mm total height of the largest diameter valve, the No. 32, projects into the atrium. Bio-prosthesis with smaller diameters have proportionally smaller height dimensions. For example, the number 22, employed for aortic valve replacement, has only a 10 mm height.
Another important feature of this bio-prosthesis is the preservation of the aortic ridge. The aortic ridge is an anatomic formation, well observed in the lumen of the ascending aorta, separating the sinuses of Valsalva from the ascending aorta. It joins the three commissures or junctions of the aortic valve.
Histological observations of the commissures and the aortic ridge indicate the importance of these anatomic structures. In a semilunar valve leaflet, the dense middle layer becomes somewhat thickened along a line close to and parallel with its free margin. At the apex of each leaflet, this thickened line is accentuated to form the Arancio's module. At the commissures this thickened line of each leaflet is closely packed, and forms an interlacing network with the connective tissue of the adjacent leaflet. This dense fibro-elastic connective tissue of each commissure becomes continuous with the connective tissue of the aortic ridge.
The preserved aortic ridge avoids overmotion of the leaflets during the opening phase of the valve. It softens the commissures' stress during closures. In other words, it is believed that the valve will perform better and will last longer because the normal functional architectures of the cusps is maintained.
The removal of the aortic ridge weakens the anatomic structures of the valve. Therefore, in order to prevent a valve's failure to operate, the commissures must necessarily be stretch-out and mounted into a frame with long struts. This is the result of other tissue valves.
The porcine aortic valve dissected from the surrounding heart's tissue is fixed and preserved in gluteraldehyde solution. When the valve is submerged in gluteraldehyde solution, the aortic ridge must be slightly dilated, with a special designed instrument, to prevent excessive contraction of the aortic ridge.
Accordingly, it was necessary to provide a low profile frame for mounting the gluteraldehyde-fixed porcine aortic valve.
In the drawing:
FIG. 1 is a side perspective view of the low profile implantable prosthetic device in accordance with the invention; and
FIG. 2 is a front view of the prosthetic device of FIG. 1.
Referring to the drawing, the prosthetic device includes a frame 1 having a cylindrical shape. The frame has a solid and slightly flexible support. However, flexibility of the frame is not indispensible. The frame's support is fabricated from a medical grade plastic material or equivalent. The frame is covered with a medical grade fabric that could be high porosity Dacron material, or equivalent.
The frame is surrounded by an extension in the form of a sewing ring 2 which is to be used for valve implantation. The bio-prosthesis used for human aortic valve replacement has a small and flat sewing ring. The illustrated sewing ring 2 is for a mitral bio-prosthesis.
The proximal end 3 of the cylindrical frame is thin and includes a non-scalloped flat rim 11 with rounded edges 12, and the distal end 4 has a wavy or scalloped shape. Both ends of the cylindrical frame are covered with fabric material to permit the suturing of the aortic ring at the proximal end, and the aortic ridge at the distal end of the three porcine leaflets or cusps 7, 8, and 9, which are fixed together at their respective commissures or junctions 10. Proximal end 3 extends beyond ring 2 in one direction, and distal end 4 extends beyond ring 2 in the opposite direction.
The bio-prosthetic device of low profile prepared from the procine aortic valve permits the tissue valve to be mounted in a low profile cylindrical frame covered with the fabric material which permits fixation when used in mitral or aortic valve replacement.
The total height of the bio-prosthetic device is approximately half or less than the dimensions of the diameter of the mounted bio-prosthesis. For example, the total height of 14 mm corresponds to the largest tissue valve in the mitral series which is the number 32. Distal end 4 of the frame has the wavy or scalloped shape, and the distal end of the mounted bio-prosthetic device also has a scalloped or wavy shape.
286 Aortic porcine fresh specimens before dissection of the valve from the surrounding tissue were studied. In addition, 30 dissected and gluteraldehyde treated porcine aortic valves were examined. The low profile frame was provided for MVR with a total height of 11-14 mm. For AVR the total height is 7-10 mm.
A hydrodynamic evaluation of the low profile valve according to the invention was done. Pressure difference across the valve, regurgitation with increasing pressures up to 500 mm Hg, closing delay and the prolonged high speed motion of the aortic cusps were studied.
Eight aortic valves numbered 20-28 mm and four mitral 26-28 mm were prepared. Ten millimeters of the body of the mitral bio-prosthesis remains in the atrium's cavity. The hydrodynamic evaluation demonstrated an absent or very low pressure gradient (15 mm Hg - 15 liters/min.). Regurgitation starts with a closing pressure exceeding 500 mm Hg. The accelerated life testing indicated a permanent durability of the tissue valves.
While there has been shown what is considered to be a preferred embodiment of the invention, it will be obvious that various changes and modifications may be made therein without departing from the spirit and scope of the invention.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US3983581 *||Nov 17, 1975||Oct 5, 1976||William W. Angell||Heart valve stent|
|1||*||"Surgery for Aortic Valve: Prosthesis and Heterograft" by M. J. Levy et al., Surgery, vol. 66, No. 2, pp. 313-318, Aug. 1969.|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US4259753 *||May 29, 1979||Apr 7, 1981||Liotta Domingo S||Frame support for cardiac tissue valves|
|US4629459 *||Dec 28, 1983||Dec 16, 1986||Shiley Inc.||Alternate stent covering for tissue valves|
|US4851000 *||Jul 31, 1987||Jul 25, 1989||Pacific Biomedical Holdings, Ltd.||Bioprosthetic valve stent|
|US4888009 *||Oct 31, 1986||Dec 19, 1989||Abiomed, Inc.||Prosthetic heart valve|
|US5509930 *||Dec 17, 1993||Apr 23, 1996||Autogenics||Stentless heart valve|
|US5855602 *||Sep 9, 1996||Jan 5, 1999||Shelhigh, Inc.||Heart valve prosthesis|
|US5861028 *||Sep 9, 1996||Jan 19, 1999||Shelhigh Inc||Natural tissue heart valve and stent prosthesis and method for making the same|
|US6165216 *||Jul 12, 1996||Dec 26, 2000||Efstathios Andreas Agathos||Human cardiac valve placement with marine mammal ventricular outflow (aortic or pulmonary) valve|
|US6334873||Sep 28, 1998||Jan 1, 2002||Autogenics||Heart valve having tissue retention with anchors and an outer sheath|
|US7785366||Nov 15, 2007||Aug 31, 2010||Maurer Christopher W||Mitral spacer|
|US7819915||Dec 19, 2003||Oct 26, 2010||Edwards Lifesciences Corporation||Heart valve holders and handling clips therefor|
|US7850143||Apr 10, 2008||Dec 14, 2010||Ggosco Engineering Inc.||Ball valve assembly|
|US8021161||May 1, 2006||Sep 20, 2011||Edwards Lifesciences Corporation||Simulated heart valve root for training and testing|
|US8092525||Oct 26, 2005||Jan 10, 2012||Cardiosolutions, Inc.||Heart valve implant|
|US8216302||Apr 28, 2009||Jul 10, 2012||Cardiosolutions, Inc.||Implant delivery and deployment system and method|
|US8308798||Dec 10, 2009||Nov 13, 2012||Edwards Lifesciences Corporation||Quick-connect prosthetic heart valve and methods|
|US8348998||Jun 23, 2010||Jan 8, 2013||Edwards Lifesciences Corporation||Unitary quick connect prosthetic heart valve and deployment system and methods|
|US8449606||May 14, 2007||May 28, 2013||Cardiosolutions, Inc.||Balloon mitral spacer|
|US8449625||Oct 27, 2009||May 28, 2013||Edwards Lifesciences Corporation||Methods of measuring heart valve annuluses for valve replacement|
|US8480730||May 14, 2007||Jul 9, 2013||Cardiosolutions, Inc.||Solid construct mitral spacer|
|US8486136||Aug 31, 2010||Jul 16, 2013||Cardiosolutions, Inc.||Mitral spacer|
|US8506623||Jul 10, 2012||Aug 13, 2013||Cardiosolutions, Inc.||Implant delivery and deployment system and method|
|US8506625||Aug 9, 2010||Aug 13, 2013||Edwards Lifesciences Corporation||Contoured sewing ring for a prosthetic mitral heart valve|
|US8518108||Aug 12, 2005||Aug 27, 2013||Edwards Lifesciences Corporation||Contoured heart valve suture rings|
|US8574257||Aug 10, 2009||Nov 5, 2013||Edwards Lifesciences Corporation||System, device, and method for providing access in a cardiovascular environment|
|US8591460||Jul 28, 2009||Nov 26, 2013||Cardiosolutions, Inc.||Steerable catheter and dilator and system and method for implanting a heart implant|
|US8597347||Nov 15, 2007||Dec 3, 2013||Cardiosolutions, Inc.||Heart regurgitation method and apparatus|
|US8641757||Jun 23, 2011||Feb 4, 2014||Edwards Lifesciences Corporation||Systems for rapidly deploying surgical heart valves|
|US8696742||Oct 10, 2012||Apr 15, 2014||Edwards Lifesciences Corporation||Unitary quick-connect prosthetic heart valve deployment methods|
|US8778017||May 14, 2007||Jul 15, 2014||Cardiosolutions, Inc.||Safety for mitral valve implant|
|US8852270||Nov 15, 2007||Oct 7, 2014||Cardiosolutions, Inc.||Implant delivery system and method|
|US8888844||Jan 10, 2012||Nov 18, 2014||Cardiosolutions, Inc.||Heart valve implant|
|US8894705||Apr 23, 2013||Nov 25, 2014||Cardiosolutions, Inc.||Balloon mitral spacer|
|US8986374||May 10, 2011||Mar 24, 2015||Edwards Lifesciences Corporation||Prosthetic heart valve|
|US9005277||Dec 21, 2012||Apr 14, 2015||Edwards Lifesciences Corporation||Unitary quick-connect prosthetic heart valve deployment system|
|US9005278||Oct 25, 2012||Apr 14, 2015||Edwards Lifesciences Corporation||Quick-connect prosthetic heart valve|
|US9078747||Nov 13, 2012||Jul 14, 2015||Edwards Lifesciences Corporation||Anchoring device for replacing or repairing a heart valve|
|US9125741||Mar 12, 2013||Sep 8, 2015||Edwards Lifesciences Corporation||Systems and methods for ensuring safe and rapid deployment of prosthetic heart valves|
|US9155617||Apr 18, 2014||Oct 13, 2015||Edwards Lifesciences Corporation||Prosthetic mitral valve|
|US9232998||Mar 15, 2013||Jan 12, 2016||Cardiosolutions Inc.||Trans-apical implant systems, implants and methods|
|US9232999||Jul 16, 2013||Jan 12, 2016||Cardiosolutions Inc.||Mitral spacer|
|US9241790||Apr 13, 2015||Jan 26, 2016||Neovasc Tiara Inc.||Transcatheter mitral valve prosthesis|
|US9248014||Apr 21, 2015||Feb 2, 2016||Neovasc Tiara Inc.||Transcatheter mitral valve prosthesis|
|US9248016||Mar 3, 2010||Feb 2, 2016||Edwards Lifesciences Corporation||Prosthetic heart valve system|
|US9259317||Sep 12, 2008||Feb 16, 2016||Cardiosolutions, Inc.||System and method for implanting a heart implant|
|US9289297||Mar 15, 2013||Mar 22, 2016||Cardiosolutions, Inc.||Mitral valve spacer and system and method for implanting the same|
|US9308087||Nov 16, 2012||Apr 12, 2016||Neovasc Tiara Inc.||Sequentially deployed transcatheter mitral valve prosthesis|
|US9314334||Nov 25, 2013||Apr 19, 2016||Edwards Lifesciences Corporation||Conformal expansion of prosthetic devices to anatomical shapes|
|US9333073||Nov 11, 2014||May 10, 2016||Edwards Lifesciences Cardiaq Llc||Vascular implant and delivery method|
|US9333074||Jan 16, 2015||May 10, 2016||Edwards Lifesciences Cardiaq Llc||Vascular implant and delivery system|
|US9339378||Jan 31, 2013||May 17, 2016||Edwards Lifesciences Cardiaq Llc||Vascular implant and delivery system|
|US9339379||Jan 31, 2013||May 17, 2016||Edwards Lifesciences Cardiaq Llc||Vascular implant and delivery system|
|US9339380||Feb 21, 2014||May 17, 2016||Edwards Lifesciences Cardiaq Llc||Vascular implant|
|US9345573 *||May 29, 2013||May 24, 2016||Neovasc Tiara Inc.||Methods and apparatus for loading a prosthesis onto a delivery system|
|US9364354||Oct 3, 2014||Jun 14, 2016||Neovasc Medical Ltd||Methods for treating abnormal growths in the body using a flow reducing implant|
|US9370418||Mar 12, 2013||Jun 21, 2016||Edwards Lifesciences Corporation||Rapidly deployable surgical heart valves|
|US9433514||Jan 9, 2012||Sep 6, 2016||Edwards Lifesciences Cardiaq Llc||Method of securing a prosthesis|
|US9439762||Jan 23, 2013||Sep 13, 2016||Edwards Lifesciences Corporation||Methods of implant of a heart valve with a convertible sewing ring|
|US9456896||Jan 22, 2013||Oct 4, 2016||Edwards Lifesciences Cardiaq Llc||Body cavity prosthesis|
|US9468527||Jun 12, 2014||Oct 18, 2016||Edwards Lifesciences Corporation||Cardiac implant with integrated suture fasteners|
|US9480560||Jan 31, 2013||Nov 1, 2016||Edwards Lifesciences Cardiaq Llc||Method of securing an intralumenal frame assembly|
|US9486336||Jan 22, 2013||Nov 8, 2016||Edwards Lifesciences Cardiaq Llc||Prosthesis having a plurality of distal and proximal prongs|
|US9504563||Jan 27, 2014||Nov 29, 2016||Edwards Lifesciences Corporation||Rapidly deployable surgical heart valves|
|US9504566||Jun 19, 2015||Nov 29, 2016||Edwards Lifesciences Corporation||Surgical heart valves identifiable post-implant|
|US9517129||Aug 13, 2013||Dec 13, 2016||Cardio Solutions, Inc.||Implant delivery and deployment system and method|
|US9532869||Jun 24, 2014||Jan 3, 2017||Edwards Lifesciences Cardiaq Llc||Vascular implant|
|US9545305||Aug 18, 2014||Jan 17, 2017||Cardiosolutions, Inc.||Mitral valve spacer and system and method for implanting the same|
|US9549816||Apr 2, 2015||Jan 24, 2017||Edwards Lifesciences Corporation||Method for manufacturing high durability heart valve|
|US9554897||Feb 8, 2013||Jan 31, 2017||Neovasc Tiara Inc.||Methods and apparatus for engaging a valve prosthesis with tissue|
|US9554901||May 11, 2011||Jan 31, 2017||Edwards Lifesciences Corporation||Low gradient prosthetic heart valve|
|US9554903||Dec 15, 2014||Jan 31, 2017||Edwards Lifesciences Corporation||Rapid deployment prosthetic heart valve|
|US9561100||Apr 10, 2015||Feb 7, 2017||Edwards Lifesciences Corporation||Systems for quickly delivering a prosthetic heart valve|
|US9572665||Apr 1, 2014||Feb 21, 2017||Neovasc Tiara Inc.||Methods and apparatus for delivering a prosthetic valve to a beating heart|
|US9585747||Jun 24, 2014||Mar 7, 2017||Edwards Lifesciences Cardiaq Llc||Vascular implant|
|US9585752||Apr 29, 2015||Mar 7, 2017||Edwards Lifesciences Corporation||Holder and deployment system for surgical heart valves|
|US20040138741 *||Dec 19, 2003||Jul 15, 2004||Robert Stobie||Heart valve holders and handling clips therefor|
|US20050228494 *||Mar 29, 2004||Oct 13, 2005||Salvador Marquez||Controlled separation heart valve frame|
|US20060009842 *||Aug 12, 2005||Jan 12, 2006||Huynh Van L||Contoured heart valve suture rings|
|US20070093890 *||Oct 26, 2005||Apr 26, 2007||Eliasen Kenneth A||Heart valve implant|
|US20070254273 *||May 1, 2006||Nov 1, 2007||Hugues Lafrance||Simulated heart valve root for training and testing|
|US20070255399 *||May 14, 2007||Nov 1, 2007||Eliasen Kenneth A||Balloon Mitral Spacer|
|US20070265700 *||May 14, 2007||Nov 15, 2007||Eliasen Kenneth A||Safety for Mitral Valve Plug|
|US20080288061 *||May 14, 2007||Nov 20, 2008||Maurer Christopher W||Solid Construct Mitral Spacer|
|US20090043382 *||Nov 15, 2007||Feb 12, 2009||Cardiosolutions, Inc.||Mitral Spacer|
|US20090048668 *||Sep 12, 2008||Feb 19, 2009||Cardiosolutions, Inc.||System and Method for Implanting a Heart Implant|
|US20090131849 *||Nov 15, 2007||May 21, 2009||Cardiosolutions, Inc.||Heart regurgitation method and apparatus|
|US20090132033 *||Nov 15, 2007||May 21, 2009||Cardiosolutions, Inc.||Implant Delivery System and Method|
|US20090240326 *||Apr 28, 2009||Sep 24, 2009||Cardiosolutions||Implant Delivery and Deployment System and Method|
|US20100022948 *||Jul 28, 2009||Jan 28, 2010||Cardiosolutions||Steerable Catheter and Dilator and System and Method for Implanting a Heart Implant|
|US20100063363 *||Aug 10, 2009||Mar 11, 2010||Hamman Baron L||System, device, and method for providing access in a cardiovascular environment|
|US20100161036 *||Dec 10, 2009||Jun 24, 2010||Edwards Lifesciences Corporation||Quick-connect prosthetic heart valve and methods|
|US20100249894 *||Mar 3, 2010||Sep 30, 2010||Edwards Lifesciences Corporation||Prosthetic heart valve system|
|US20100249908 *||Mar 2, 2010||Sep 30, 2010||Edwards Lifesciences Corporation||Prosthetic heart valve system with positioning markers|
|US20100324668 *||Aug 31, 2010||Dec 23, 2010||Cardiosolutions, Inc.||Mitral Spacer|
|US20100331972 *||Jun 23, 2010||Dec 30, 2010||Edwards Lifesciences Corporation||Unitary Quick Connect Prosthetic Heart Valve and Deployment System and Methods|
|US20110054598 *||Aug 9, 2010||Mar 3, 2011||Edwards Lifesciences Corporation||Contoured Sewing Ring for a Prosthetic Mitral Heart Valve|
|US20110098602 *||Oct 27, 2009||Apr 28, 2011||Edwards Lifesciences Corporation||Apparatus and Method for Measuring Body Orifice|
|US20140155990 *||May 29, 2013||Jun 5, 2014||Neovasc Inc.||Methods and apparatus for loading a prosthesis onto a delivery system|
|US20150039081 *||Jul 31, 2013||Feb 5, 2015||Medtronic Vascular Galway||Mitral Valve Prosthesis for Transcatheter Valve Implantation|
|USD755384||Mar 5, 2014||May 3, 2016||Edwards Lifesciences Cardiaq Llc||Stent|
|DE4234127A1 *||Oct 9, 1992||May 26, 1994||Vetter Herbert Dr||Heart valve prosthesis - comprises distributor mitral valve which can be fixed to heart wall with aid of plastic patches|
|EP0051451A2 *||Oct 29, 1981||May 12, 1982||Shiley Incorporated||Low profile prosthetic xenograft heart valve|
|EP0051451A3 *||Oct 29, 1981||Jun 30, 1982||Shiley Incorporated||Low profile prosthetic xenograft heart valve|
|EP0125393A1 *||Oct 29, 1981||Nov 21, 1984||Shiley Incorporated||Prosthetic heart valve|
|U.S. Classification||623/2.17, 623/900|
|Cooperative Classification||A61F2/2412, A61F2/2409, Y10S623/90|
|European Classification||A61F2/24D, A61F2/24C|
|Sep 11, 1986||AS||Assignment|
Owner name: BIOIMPLANT CANADA, INC., A CANADIAN CORP.
Free format text: GRANTS AN IRREVOCABLE, NON-EXCLUSIVE LICENSE TO PRACTICE UNDER SAID INVENTION;ASSIGNOR:CAIVANO, FELIX O.;REEL/FRAME:004632/0462
Effective date: 19860905
Owner name: CAVIANO, FELIX ORLANDO
Free format text: ASSIGNMENT OF A PART OF ASSIGNORS INTEREST;ASSIGNORS:LIOTTA, DOMINGO S.;DE LIOTTA, HOLGA ESTHER TRONCOSO;REEL/FRAME:004632/0466
Effective date: 19860901
Owner name: ST. JUDE MEDICAL, LTD.
Free format text: GRANTS AN IRREVOCABLE, NON-EXCLUSIVE WORLD WIDE LICENSE TO PRACTICE UNDER SAID INVENTION, SUBJECT TO AGREEMENT DATED AUGUST 22, 1986;ASSIGNOR:BIOIMPLANT CANADA, INC.;REEL/FRAME:004632/0464
Effective date: 19860905